Recall Issued for Testosterone Pellets Due to Glass Contamination Risk

The US Food and Drug Administration (FDA) has issued a Class II recall for multiple lots of Testosterone Pellets (100 mg and 200 mg, including blunt formulations), due to the presence of glass particulate matter found in pellet vials. The recall involves more than 8500 vials across 6 distinct lot groups, with expiration dates ranging from December 11, 2025, to January 31, 2026. The recall was initiated by BSO LLC, based in Lakewood, Colorado, on April 28, 2025, and applies to products distributed nationwide in the United States.

The FDA classified the recall as Class II on May 6, 2025, indicating that exposure to the affected products may cause temporary or medically reversible health issues, but the likelihood of serious injury is low. No public press release has been issued, but the firm has notified consignees by letter. 

Testosterone pellets are typically used as hormone replacement therapy (HRT) in individuals with testosterone deficiency (hypogonadism). Implanted subcutaneously, these pellets provide sustained testosterone release over several months. The presence of glass particles in injectable or implantable products is a significant safety concern, as it may lead to inflammation, local tissue damage, or systemic embolic events.